BEUDAMED
    FDA Recall Terminated

    Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306

    Recall: Z-0535-06 · Initiated November 29, 2005

    Recall

    Recall Number
    Z-0535-06
    Event Number
    34093
    Firm
    Medtronic Inc. Cardiac Rhythm Managment
    FEI Number
    2182208
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 29, 2005
    Posted
    February 18, 2006
    Terminated
    January 4, 2007
    Address
    7000 Central Ave Ne, Fridley, MN, 55432

    Description

    Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306

    Reason

    An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.

    Action

    Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.

    Distribution

    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

    Quantity

    12,756